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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

the number of active Medical Devices Establishment Licenses and where the license holders are located

the type of activity of the MDEL holders (Class 1 manufacturer, importer or distributor)

the average review time for a new MDEL submission over the period of 01 April 2013 to 31 March 2014 and the average review time for a MDEL renewal (Annual Review) over the same period

the amount of total fees collected by Health Canada for MDEL holders and the average fees for MDEL holders that were subject to fees

Health Canada’s reply can be summarized as follows:

MDELs Issued

Health Canada disclosed that there were 2473 MDELs issued as of 31 March 2014, of which:

1784 (72%) licence holders were based in Canada.

581 (23%) license holders were based in the United States.

The remaining 108 (4%) were spread across 24 other countries.

Regarding activity:

602 (24%) of the MDEL holders were registered solely as Manufacturers of Class 1 medical devices.

547 (22%) of the MDEL holders were importers only (the Health Canada definition of “importer” means that they are based in Canada).

Of the 378 (15%) MDEL holders that identified distribution as their only activity, 195 were based outside of Canada (96% of these were based in the US).

Average Review Times

For Health Canada’s last fiscal year (ending 31 March 2014), they reported that new MDEL applications were taking an average of 53 calendar days to review. Over the same period, the average review time for an MDEL Annual Review (renewal) was 44 days.

MDEL Fees

With respect to MDEL fees, Health Canada disclosed:

2382 MDEL holders had initiated the renewal of their MDEL prior to 31 March 2014, of which 2118 MDEL holders paid a total of $8.9 million.

1298 MDEL holders received some level of fee remission (based on sales).

186 MDEL holders paid $0 (no sales).

264 MDEL holders had their fees deferred to the next year (i.e. new licensees).

Of the $8.9 million collected in MDEL fees, a total of $6 million was collected from those MDEL holders that did not receive a fee remission Therefore, of the 1,298 MDEL holders that received a fee remission, the average fee was $2283, which equates to a reduction of approximately $5000 for each MDEL holder in this scenario.

Key Takeaways

The key takeaways from the data collected from Health Canada on Medical Device Establishment Licenses are:

Health Canada takes between 40 and 55 days to review MDEL renewal and new MDEL applications, respectively.

Companies that apply for a fee remission as part of the MDEL Annual Review pay an average of $5000 less in fees for their MDELs.